Table 1.
Baseline characteristics in the vitamin D and placebo study arms (N = 259)
|
Baseline characteristic |
Randomization |
|
|---|---|---|
| Drug intervention (n = 132) | Placebo intervention (n = 127) | |
| Age (years), Mean ± SD |
27.8 ± 13.2 |
28.3 ± 14.1 |
| Gender, Men |
71 (53.8) |
70 (55.1) |
| Weight (kg), Mean ± SD |
45.2 ± 7.6 |
45.6 ± 9.0 |
| BMI, Mean (range) |
17.2 (11–25) |
17.3 (11–27) |
| MUAC (cm), (range) |
21.2 (14–30) |
21.1 (15–32) |
| Disease Symptom(s)present |
|
|
| Cough |
127 (96.2) |
125 (98.4) |
| Haemoptysis |
30 (22.7) |
34 (26.8) |
| Dyspnoea |
84 (63.6) |
85 (66.9) |
| Chest pain |
84 (63.6) |
84 (66.1) |
| Night sweats |
69 (52.3) |
55 (43.3) |
| Pale conjunctiva |
70 (53) |
67 (52.8) |
| Tachycardia |
87 (65.9) |
86 (67.7) |
| Fever |
49 (37.1) |
68 (53.5) |
| Crepitations |
50 (37.9) |
38 (29.9) |
| Rhonchi |
19 (14.4) |
21 (16.5) |
| Reduced breath sounds |
26 (19.7) |
20 (15.7) |
| TB score, Mean ± SD, 95 CI |
6.68 ± 2.04, 6.3-7.03 |
6.85 ± 2.50, 6.4-7.29 |
| Distribution by Severity Class/TB score* |
|
|
| Class I/0 – 5 |
32 (24.2) |
40 (31.5) |
| Class II/6 – 7 |
51 (38.6) |
41 (32.3) |
| Class III/≥ 8 |
49 (37.1) |
46 (36.2) |
| Serum-25-(OH)D3 levels; Mean, (SD) |
20.58 ± 8.51 |
22.87 ± 10.33 |
| 25(OH)D3 >30 ng/ml (Optimal) |
18 (13.6) |
25 (19.7) |
| 25(OH)D3 20-30 ng/ml (Insufficient) |
46 (34.8) |
54 (42.5) |
| 25(OH)D3 < 20 ng/ml (Deficient) |
70 (53) |
51(41) |
| Chest X-Ray Classification1 |
|
|
| Minimally Advanced disease |
10 (7.6) |
13 (10.2) |
| Moderately Advanced disease |
77 (58.3) |
62 (48.8) |
| Far Advanced disease |
45 (34.1) |
52 (40.9) |
| No Cavity |
7 (5.3) |
4 (3.1) |
| Cavity size < 4 cm |
60 (45.5) |
59 (46.5) |
| Cavity size ≥ 4 cm |
65 (49.2) |
64 (50.4) |
| No. of zones involved 3, Mean ± SD |
3.61 ± 1.40 |
3.64 ± 1.48 |
| Sputum microbial load (microscopy)2 |
|
|
| Scant, 1–9 AFB/100 fields |
4 (3.0) |
2 (1.6) |
| +1, 10–99 AFB/100 fields, |
36 (27.3) |
34 (26.8) |
| +2, 1–10 AFB/50 fields, |
25 (18.9) |
23 (18.1) |
| +3, >10 AFB/20 fields, |
67 (50.8) |
68 (53.5) |
|
IFN-g levels (pg/ml) mean ± SD |
|
|
| Unstimulated levels |
0.2 ± 2.6 |
0 ±0 |
| ESAT6-stimulated |
413 ±977 |
303 ±804 |
| MTBs-stimulated | 2826 ±1391 | 2858 ±1337 |
MUAC Mid Upper Arm Circumference; BMI Body Mass Index; s-25-(OH)D3 = serum 25- hydroxyvitamin D3.* Severity Class (TB score) [10];1Chest X ray classification: Each hemi-lung was divided into 3 zones (total 6 lung zones): active parenchymal and cavitary disease, exclusive of old fibrotic scarring, recorded as ‘zone involvement’ [11,12]. 2Diagnostic Standards and Classification of Tuberculosis, National Tuberculosis Association of the USA, 1961. Data are presented here as number (%), unless stated otherwise.